Gho Pharma BV has announced the development of an innovative treatment for severe burn wounds in children. The company plans to request an orphan drug designation, based on the fact that fewer than 200 000 patients annually suffer from severe burns.
Each year, thousands of children suffer burn-related accidents, often with long-lasting consequences and disfigurement. Burn injuries constitute one of the greatest hazards of childhood, and infants are at higher risk of death from burns than adults. Currently there are no drugs available to treat severe burns in children. This might change in the coming years.
The compound, bis(maltolato)oxovanadium (BMOV), an organic vanadium salt, has been studied by the founder of the company, Dr C. Gho, in animal studies using a standardized pig model of burn wounds. When administered intravenously following the burn injury BMOV has been shown to promote wound healing significantly, leading to the formation of thinner, more supple scars with less contraction, and better preservation of hair follicles and sweat glands.
Investigations of the wound healing have shown that vascularization of the wound was better in treated pigs and the development of granulation tissue was less extensive. The re-epithelialization of the wound was also more rapid in BMOV-treated animals. The magnitude of this effect appeared to be dose-related following intravenous bolus injection.
BMOV acts by limiting or preventing the secondary injury which arises as a result of tissue damage caused by the actual burn trauma or primary injury. By administering the compound intravenously, we can ensure that it reaches the target area directly. BMOV has undergone a full animal toxicological testing program using intravenous administration. In a recent human Phase I study in healthy volunteers, there were no drug-related and dose-limiting side-effects at the anticipated effective dose level.
In early 2003 Gho Pharma is planning to start a large pivotal multi-center study of BMOV in children with hot-water burns, in cooperation with some major European Burn Centres. The company is currently contemplating a new finance round to support the pivotal trial program.